JAMA Cardiology publishes EBR’s pivotal SOLVE-CRT study
The SOLVE-CRT trial evaluated patients indicated for CRT who were previously untreatable or considered high risk upgrades. The study found that the WiSE System, the only leadless left ventricular endocardial pacing (LVEP) device, can safely deliver CRT.
- 16.4% improvement in left ventricular end systolic volume (LVESV), in heart failure patients in the first 6-months.
- 80.9% of patients had no serious procedure or device-related complications in the first 6-months.
WiSE Clinical Program
Studies demonstrate on-going clinical impact of WiSE System, the leadless left ventricular endocardial pacing (LVEP) solution.
WiSE-CRT
SELECT-LV
Post-Market Surveillance Registry
SOLVE-CRT
Study Design
Single-arm, safety and feasibility
Single-arm, safety and efficacy
Real-world safety and performance
Single-arm, Roll-in
Pivotal: randomized and single-arm
# of Patients
13
34
153
31
183
# of Sites
11
7
19
68
Regions
EU
EU
EU, UK
AU, EU, UK, US
Publications
Clinical Study References
Elliott MK, Jacon P, Sidhu BS, Smith LJ, Mehta VS, Gould J, Lee AWC, Niederer S, Defaye P, Rinaldi CA. Technical feasibility of leadless left bundle branch area pacing for cardiac resynchronization: a case series. Eur Heart J Case Rep. 2021 Sep 24.Elliott MK, Jacon P, Sidhu BS, Smith LJ, Mehta VS, Gould J, Lee AWC, Niederer S, Defaye P, Rinaldi CA. Technical feasibility of leadless left bundle branch area pacing for cardiac resynchronization: a case series. Eur Heart J Case Rep. 2021 Sep 24.
Sidhu BS, Sieniewicz B, Gould J, Elliott MK, Mehta VS, Betts TR, James S, Turley AJ, Butter C, Seifert M, Boersma LVA, Riahi S, Neuzil P, Biffi M, Diemberger I, Vergara P, Arnold M, Keane DT, Defaye P, Deharo JC, Chow A, Schilling R, Behar JM, Leclercq C, Auricchio A, Niederer SA, Rinaldi CA. Leadless left ventricular endocardial pacing for CRT upgrades in previously failed and high-risk patients in comparison with coronary sinus CRT upgrades. Europace. 2021 Jul 28:euab156.Sidhu BS, Sieniewicz B, Gould J, Elliott MK, Mehta VS, Betts TR, James S, Turley AJ, Butter C, Seifert M, Boersma LVA, Riahi S, Neuzil P, Biffi M, Diemberger I, Vergara P, Arnold M, Keane DT, Defaye P, Deharo JC, Chow A, Schilling R, Behar JM, Leclercq C, Auricchio A, Niederer SA, Rinaldi CA. Leadless left ventricular endocardial pacing for CRT upgrades in previously failed and high-risk patients in comparison with coronary sinus CRT upgrades. Europace. 2021 Jul 28:euab156.
Okabe T, Hummel JD, Bank AJ, Niazi IK, McGrew FA, Kindsvater S, Oza SR, Scherschel JA, Walsh MN, Singh JP. Leadless left ventricular stimulation with WiSE-CRT System – Initial experience and results from phase I of SOLVE-CRT Study (nonrandomized, roll-in phase). Heart Rhythm. 2021 Jul 23:S1547-5271(21)01808-7.Okabe T, Hummel JD, Bank AJ, Niazi IK, McGrew FA, Kindsvater S, Oza SR, Scherschel JA, Walsh MN, Singh JP. Leadless left ventricular stimulation with WiSE-CRT System – Initial experience and results from phase I of SOLVE-CRT Study (nonrandomized, roll-in phase). Heart Rhythm. 2021 Jul 23:S1547-5271(21)01808-7.
Sidhu BS, Gould J, Elliott M, et.al. Leadless left ventricular endocardial pacing and left bundle branch area pacing for cardiac resynchronisation therapy. AER 2021;10(1):45-50.Sidhu BS, Gould J, Elliott M, et.al. Leadless left ventricular endocardial pacing and left bundle branch area pacing for cardiac resynchronisation therapy. AER 2021;10(1):45-50.
Singh JP, Walsh MN, Kubo SH, et.al. Modified design of stimulation of the left ventricular endocardium for cardiac resynchronization therapy in nonresponders, previously untreatable and high-risk upgrade patients (SOLVE-CRT) trial. Am Heart Journal. 2021 (235):158-162.Singh JP, Walsh MN, Kubo SH, et.al. Modified design of stimulation of the left ventricular endocardium for cardiac resynchronization therapy in nonresponders, previously untreatable and high-risk upgrade patients (SOLVE-CRT) trial. Am Heart Journal. 2021 (235):158-162.
Carabelli A, Jabeur M, Jacon P, et.al. European experience with a first totally leadless cardiac resynchronization therapy pacemaker system. EP Europace 2020; euaa342.Carabelli A, Jabeur M, Jacon P, et.al. European experience with a first totally leadless cardiac resynchronization therapy pacemaker system. EP Europace 2020; euaa342.
Sidhu BS, Gould J, Porter B, et.al. Completely leadless cardiac resynchronization defibrillator system. JACC EP 2020;6(5):588-589.Sidhu BS, Gould J, Porter B, et.al. Completely leadless cardiac resynchronization defibrillator system. JACC EP 2020;6(5):588-589.
Sidhu BS, Porter B, Gould J, et.al. Leadless left ventricular endocardial pacing in nonresponders to conventional cardiac resynchronization therapy. PACE 2020;43(9):966-973.Sidhu BS, Porter B, Gould J, et.al. Leadless left ventricular endocardial pacing in nonresponders to conventional cardiac resynchronization therapy. PACE 2020;43(9):966-973.
Sieniewicz BJ, Betts TR, James S, et.al. Real-world experience of leadless left ventricular endocardial cardiac resynchronization therapy: A multicenter international registry of the WiSE-CRT pacing system. Heart Rhythm 2020;17(8):1291-1297.Sieniewicz BJ, Betts TR, James S, et.al. Real-world experience of leadless left ventricular endocardial cardiac resynchronization therapy: A multicenter international registry of the WiSE-CRT pacing system. Heart Rhythm 2020;17(8):1291-1297.
Singh J, Abraham W, Auricchio A et.al Design and rationale for the stimulation of the left ventricular endocardium for cardiac resynchronization therapy in non-responders and previously untreatable patients (SOLVE-CRT) trial. Am Heart Journal. 2019 epub before print.Singh J, Abraham W, Auricchio A et.al Design and rationale for the stimulation of the left ventricular endocardium for cardiac resynchronization therapy in non-responders and previously untreatable patients (SOLVE-CRT) trial. Am Heart Journal. 2019 epub before print.
Sidhu B, Lee A,Haberland U, Rajani, R, Niederer S, Rinaldi C. Combined computed tomographic perfusion and mechanics with predicted activation pattern can successfully guide implantation of a wireless endocardial pacing system. Europace. 2019 Aug 27.Sidhu B, Lee A,Haberland U, Rajani, R, Niederer S, Rinaldi C. Combined computed tomographic perfusion and mechanics with predicted activation pattern can successfully guide implantation of a wireless endocardial pacing system. Europace. 2019 Aug 27.
Montemerlo E, Pozzi M,de Ceglia S, Santini F, Piazzi E, Rovaris G. First‐in‐man fully leadless transvenous CRT‐P with a transseptal implant of WISE‐CRT® system and Micra® PM. Pace. 2019 Jun 21.Montemerlo E, Pozzi M,de Ceglia S, Santini F, Piazzi E, Rovaris G. First‐in‐man fully leadless transvenous CRT‐P with a transseptal implant of WISE‐CRT® system and Micra® PM. Pace. 2019 Jun 21.
Twomey D, Riahi S, Turley AJ, James S. Left Ventricular Endocardial Pacing With a Novel Wireless CRT System Pacing Threshold Trend: Medium Term 2-Year Data. JACC EP. 2019 May;5(5):635-636.Twomey D, Riahi S, Turley AJ, James S. Left Ventricular Endocardial Pacing With a Novel Wireless CRT System Pacing Threshold Trend: Medium Term 2-Year Data. JACC EP. 2019 May;5(5):635-636.
Sieniewicz B, Betts T, James S, Turley A, Rinaldi C et.al. Guidance for optimal Site Selection of a Leadless LV endocardial Electrode Improves Acute Hemodynamic Response and Chronic Remodeling. JACC-EP. 2018 May 02, 2018Sieniewicz B, Betts T, James S, Turley A, Rinaldi C et.al. Guidance for optimal Site Selection of a Leadless LV endocardial Electrode Improves Acute Hemodynamic Response and Chronic Remodeling. JACC-EP. 2018 May 02, 2018
Leo M, Webster D, Betts TR. Acute electrical and hemodynamic effects of endocardial biventricular pacing using the WiSE CRT system and conventional epicardial biventricular pacing. J Arrhythmia. 2018;34:87–89.Leo M, Webster D, Betts TR. Acute electrical and hemodynamic effects of endocardial biventricular pacing using the WiSE CRT system and conventional epicardial biventricular pacing. J Arrhythmia. 2018;34:87–89.
Sieniewicz BJ, Gould JS, Rimington HM, et al. Transseptal Delivery of a Leadless Left Ventricular Endocardial Pacing Electrode. JACC Clin EP. 2017 Nov. 3(11):1333-5.Sieniewicz BJ, Gould JS, Rimington HM, et al. Transseptal Delivery of a Leadless Left Ventricular Endocardial Pacing Electrode. JACC Clin EP. 2017 Nov. 3(11):1333-5.
Seifert M, Fehrendt S, Moeller V, et al. LV endocardial wireless pacing for heart failure (WiSE-CRT): What are the parameters relevant for longevity in long term course? Europace (2017) 19 (Supplement 3), iii19.Seifert M, Fehrendt S, Moeller V, et al. LV endocardial wireless pacing for heart failure (WiSE-CRT): What are the parameters relevant for longevity in long term course? Europace (2017) 19 (Supplement 3), iii19.
Twomey D, Thomas D, Beaney E, et al. WiCS leadless CRT system implantation: determining optimal endocardial LV electrode position using preprocedural strain echocardiography. Europace (2017) 19 (Supplement 3), iii111.Twomey D, Thomas D, Beaney E, et al. WiCS leadless CRT system implantation: determining optimal endocardial LV electrode position using preprocedural strain echocardiography. Europace (2017) 19 (Supplement 3), iii111.
Behar JM, James S, Betts TR , et al. A multi centre UK experience with optimal site implantation of a wireless intracardiac LV endocardial electrode (WiCS-LV) for delivery of cardiac resynchronisation therapy. Europace (2017) 19 (Supplement 3), iii24.Behar JM, James S, Betts TR , et al. A multi centre UK experience with optimal site implantation of a wireless intracardiac LV endocardial electrode (WiCS-LV) for delivery of cardiac resynchronisation therapy. Europace (2017) 19 (Supplement 3), iii24.
Fehrendt SF, Seifert MS, Moeller VM, et al. Long term results of the leadless CRT (WiSE-CRT) in patients with failed implantation of a conventional CRT device. Europace (2017) 19 (Supplement 3), iii16.Fehrendt SF, Seifert MS, Moeller VM, et al. Long term results of the leadless CRT (WiSE-CRT) in patients with failed implantation of a conventional CRT device. Europace (2017) 19 (Supplement 3), iii16.
Reddy VY, Miller MA, Neuzil P, et al. Cardiac Resynchronization Therapy With Wireless Left Ventricular Endocardial Pacing: The SELECT-LV Study. J Am Coll Cardiol. 2017 May 2;69(17):2119-2129.Reddy VY, Miller MA, Neuzil P, et al. Cardiac Resynchronization Therapy With Wireless Left Ventricular Endocardial Pacing: The SELECT-LV Study. J Am Coll Cardiol. 2017 May 2;69(17):2119-2129.
Behar JM, James S, Betts TR, et al. Clinical experience of optimal site selection with a wireless intracardiac LV endocardial electrode (WiCS-LV) for delivery of cardiac resynchronization therapy: a multicenter UK study. HRS 2017 May. Abstract C-AB34-02.Behar JM, James S, Betts TR, et al. Clinical experience of optimal site selection with a wireless intracardiac LV endocardial electrode (WiCS-LV) for delivery of cardiac resynchronization therapy: a multicenter UK study. HRS 2017 May. Abstract C-AB34-02.
James S, Twomey DJ, Butter C, Riahi, S, Turley, A. Left Ventricular Endocardial Pacing with a Novel Wireless CRT System (WiSE-CRT): Pacing Threshold Trends: Medium Term 2-Year Data. HRS 2017 May. Abstract C-AB34-01.James S, Twomey DJ, Butter C, Riahi, S, Turley, A. Left Ventricular Endocardial Pacing with a Novel Wireless CRT System (WiSE-CRT): Pacing Threshold Trends: Medium Term 2-Year Data. HRS 2017 May. Abstract C-AB34-01.
Sieniewicz B , Behar J, Sohal M, et al. Identifying the optimal location for LV endocardial pacing: results from a multicentre international registry. Europace (2017) 19 (Supplement 3), iii144.Sieniewicz B , Behar J, Sohal M, et al. Identifying the optimal location for LV endocardial pacing: results from a multicentre international registry. Europace (2017) 19 (Supplement 3), iii144.
Thomas D, Child NM, Owens WA, Linker NJ, James SA, Turley AJ. Cardiac resynchronization therapy in coronary sinus atresia delivered using leadless endocardial pacing. Heart Rhythm Case Reports. 2016 September;2:432–435.Thomas D, Child NM, Owens WA, Linker NJ, James SA, Turley AJ. Cardiac resynchronization therapy in coronary sinus atresia delivered using leadless endocardial pacing. Heart Rhythm Case Reports. 2016 September;2:432–435.
Behar JM, Jackson T, Hyde E, et al. Optimized Left Ventricular Endocardial Stimulation Is Superior to Optimized Epicardial Stimulation in Ischemic Patients With Poor Response to Cardiac Resynchronization Therapy. 2016 June. JACC Clinical EP.Behar JM, Jackson T, Hyde E, et al. Optimized Left Ventricular Endocardial Stimulation Is Superior to Optimized Epicardial Stimulation in Ischemic Patients With Poor Response to Cardiac Resynchronization Therapy. 2016 June. JACC Clinical EP.
Seifert M, Butter C. Evaluation of wireless stimulation of the endocardium, WiSE, technology for treatment heart failure. 2016 May. Expert Review of Medical Devices Vol. 13, Iss. 6.Seifert M, Butter C. Evaluation of wireless stimulation of the endocardium, WiSE, technology for treatment heart failure. 2016 May. Expert Review of Medical Devices Vol. 13, Iss. 6.
Reddy VY, Neuzil P, Riahi S, et al. Leadless LV Endocardial Stimulation for CRT: Final Outcomes of the Safety and Performance of Electrodes Implanted in the Left Ventricle (SELECT-LV) Study. Heart Rhythm 2016 May;13(5): AB17-02.Reddy VY, Neuzil P, Riahi S, et al. Leadless LV Endocardial Stimulation for CRT: Final Outcomes of the Safety and Performance of Electrodes Implanted in the Left Ventricle (SELECT-LV) Study. Heart Rhythm 2016 May;13(5): AB17-02.
Riahi S, Søgaard P, Reddy VY, et al. Wireless LV Endocardial Stimulation for CRT, SELECT-LV Study: Performance and Preliminary Efficacy in Ischaemic Patients. Heart Rhythm 2016 May;13(5): AB17-05.Riahi S, Søgaard P, Reddy VY, et al. Wireless LV Endocardial Stimulation for CRT, SELECT-LV Study: Performance and Preliminary Efficacy in Ischaemic Patients. Heart Rhythm 2016 May;13(5): AB17-05.
Neuzil P, Reddy VY, Sedivy P, et al. Wireless LV Endocardial Stimulation for CRT: Long-term (12 month) Experience of Clinical Efficacy and Clinical Events from Two Centers. Heart Rhythm 2016 May;13(5): AB17-01.Neuzil P, Reddy VY, Sedivy P, et al. Wireless LV Endocardial Stimulation for CRT: Long-term (12 month) Experience of Clinical Efficacy and Clinical Events from Two Centers. Heart Rhythm 2016 May;13(5): AB17-01.
Miller M, Neuzil P, Dukkipati SR, Reddy VY. Leadless Cardiac Pacemakers, Back to the Future. Journal of the American College of Cardiology. 2015 September;66(10):1179-1189.Miller M, Neuzil P, Dukkipati SR, Reddy VY. Leadless Cardiac Pacemakers, Back to the Future. Journal of the American College of Cardiology. 2015 September;66(10):1179-1189.
Reddy VY, Sedivy P, Mraz T, et al. Wireless LV Endocardial Stimulation for Cardiac Resynchronization: Single center experience in the SELECT-LV Study. HRS 2015 May: PO02-186.Reddy VY, Sedivy P, Mraz T, et al. Wireless LV Endocardial Stimulation for Cardiac Resynchronization: Single center experience in the SELECT-LV Study. HRS 2015 May: PO02-186.
Reddy VY, Neuzil P, Riahi S, et al. Wireless LV endocardial stimulation for CRT: Primary results of the Safety and Performance of Electrodes implanted in the Left Ventricle (SELECT-LV) Study. HRS 2015 May: Late Breaking clinical trials, LBCT01-05.Reddy VY, Neuzil P, Riahi S, et al. Wireless LV endocardial stimulation for CRT: Primary results of the Safety and Performance of Electrodes implanted in the Left Ventricle (SELECT-LV) Study. HRS 2015 May: Late Breaking clinical trials, LBCT01-05.
Neuzil P, Sedivy P, Mraz T, et al. Wireless LV Endocardial Stimulation for CRT: SELECT-LV study. Europace 2014 June; Vol. 16, Sup. 2: 35.Neuzil P, Sedivy P, Mraz T, et al. Wireless LV Endocardial Stimulation for CRT: SELECT-LV study. Europace 2014 June; Vol. 16, Sup. 2: 35.
Delnoy PP , Butter C, Brachmann J, et al. Wireless LV endocardial CRT in ischaemic cardiomyopathy. Europace 2014 June; Vol. 16, Sup. 2: 35.Delnoy PP , Butter C, Brachmann J, et al. Wireless LV endocardial CRT in ischaemic cardiomyopathy. Europace 2014 June; Vol. 16, Sup. 2: 35.
Auricchio A, Delnoy PP, Butter C, et al. Feasibility, safety, and short-term outcome of leadless ultrasound-based endocardial left ventricular resynchronization in heart failure patients: results of the Wireless Stimulation Endocardially for CRT (WiSE-CRT) study. Europace 2014 May; 16(5): 681-8.Auricchio A, Delnoy PP, Butter C, et al. Feasibility, safety, and short-term outcome of leadless ultrasound-based endocardial left ventricular resynchronization in heart failure patients: results of the Wireless Stimulation Endocardially for CRT (WiSE-CRT) study. Europace 2014 May; 16(5): 681-8.
Reddy VY, Sedivy P, Mraz T, et al. Wireless LV endocardial stimulation for cardiac resynchronization: Initial experience from the SELECT-LV study. Heart Rhythm 2014 May; 11(5): 41.Reddy VY, Sedivy P, Mraz T, et al. Wireless LV endocardial stimulation for cardiac resynchronization: Initial experience from the SELECT-LV study. Heart Rhythm 2014 May; 11(5): 41.
Butter C, Delnoy PP, Erven LV, et al. Wireless left ventricular endocardial cardiac resynchronization in heart failure patients: 12 months follow-up. European Heart Journal (2014) 35 (Abstract Supplement), 161-162.Butter C, Delnoy PP, Erven LV, et al. Wireless left ventricular endocardial cardiac resynchronization in heart failure patients: 12 months follow-up. European Heart Journal (2014) 35 (Abstract Supplement), 161-162.
Auricchio A, Delnoy PP, Regoli F, Seifert M, Markou T, Butter C. First-in-man implantation of leadless ultrasound-based cardiac stimulation pacing system: novel endocardial left ventricular resynchronization therapy in heart failure patients. Europace 2013 May; 15: 1191-7.Auricchio A, Delnoy PP, Regoli F, Seifert M, Markou T, Butter C. First-in-man implantation of leadless ultrasound-based cardiac stimulation pacing system: novel endocardial left ventricular resynchronization therapy in heart failure patients. Europace 2013 May; 15: 1191-7.